UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052408 |
|---|---|
| Receipt number | R000059613 |
| Scientific Title | A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations identified by multiplex companion diagnostics |
| Date of disclosure of the study information | 2023/10/06 |
| Last modified on | 2023/10/10 08:23:34 |
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Basic information
Public title
A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations
Acronym
A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations
Scientific Title
A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations identified by multiplex companion diagnostics
Scientific Title:Acronym
A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the clinical utility of comprehensive genomic profiling in patients with advanced or recurrent non-small cell lung cancer who have no driver genetic alterations that are druggable by approved agents and who have completed or are expected to complete standard treatment.
Basic objectives2
Others
Basic objectives -Others
To evaluate the proportion of patients with actionable cancer genomic alterations detected using comprehensive genomic profiling tests.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with actionable cancer genomic alterations detected using comprehensive genomic profiling tests.
Key secondary outcomes
The proportion of patients with options of molecular-based recommended therapy (MBRT) determined by the molecular tumor board.
The proportion of patients with druggable genomic alterations.
The proportion of patients who received MBRT including clinical trials.
The success rate of the comprehensive genomic profiling tests.
Matching score of MBRT calculated using a matching score system.
Response rate and progression-free survival in the treatment after comprehensive genomic profiling.
Overall survival.
Progression-free survival in MBRT.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age equal to or more than 20 years at the time of study entry
2. Locally advanced, recurrent, or metastatic non-small cell lung cancer without druggable driver genetic alterations assessed by multiplex companion diagnostics
3. Standard treatment has been completed or is expected to be completed
4. Comprehensive genomic profiling tests are planned
5. Written informed consent obtained from the subject
Key exclusion criteria
1. Patients who do not meet the insurance coverage of the National Health Insurance in Japan for comprehensive genomic profiling testing
2. Patients with driver genetic alterations that are druggable by approved agents determined by multiplex companion diagnostics at the time of diagnosis
3. Patients who received more than one line of systemic treatment after the completion of standard treatment
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
81-53-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
81-53-435-2263
Homepage URL
yinoue@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
Tel
81-53-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multi-institutional, prospective, cohort study to assess the clinical utility of comprehensive genomic profiling in patients with advanced or recurrent non-small cell lung cancer who have no driver genetic alterations that are druggable by approved agents determined by multiplex companion diagnostics and who have completed or are expected to complete standard treatment.
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059613
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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